Testing services / Particulate matter in injections according to USP <788> and Ph. Eur. 2.9.19

Particulate matter in injections according to USP <788> and Ph. Eur. 2.9.19

Quantification of subvisible particulate matter in injectable and parenteral solutions according to USP <788> or the harmonized method Ph. Eur. 2.9.19. Testing is commonly performed as part of batch release and compliance verification against particle count limits.

We offer both methods specified in USP <788> and Ph. Eur. 2.9.19:

Method 1: Light obscuration particle count
Method 2: Microscopic particle count

Method 1 is generally preferred unless the sample is not suited to it, for example, because of high viscosity, opacity, or a tendency to form gas bubbles. In some cases, it may be necessary to perform both tests (e.g., when Method 1 results are borderline).

Results are reported as particle counts by size range per container or per specified sampling unit. A comparison against the applicable pharmacopoeial limits or customer-defined specifications is also provided.

Suitable sample matrices: Parenteral pharmaceutical products intended for intramuscular, subcutaneous, or intravenous administration; sterilized water for injections
Required sample quantity: 3-5 pieces/material
Typical turnaround time: 5 – 6 weeks after receiving the samples
Available quality systems: Accredited testing laboratory, GMP test method
Standard: USP 788
Method expert: Elina Tenhunen

Pharmaceuticals

Particle testing

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